check_circleStudy Completed

Erythema

Bayer Identifier:

12039

ClinicalTrials.gov Identifier:

NCT00839462

EudraCT Number:

Not Available

EU CT Number:

Not Available
Efficacy of Dexpanthenol in thermic erythema

Trial purpose

The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - Healthy subjects
    - Phototype: I to IV according to Fitzpatrick scale
  • - Pregnant or nursing women
    - Subjects registered as being in exclusion period in the French Health Minister file of subjects
    - Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

Trial summary

Enrollment Goal
55
Trial Dates
September 2007 - September 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
VILLEURBANNE, 69100, France

Primary Outcome

  • Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
    date_rangeTime Frame:
    2 min, 5 min, 10 min, 15 min
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Skin temperature
    date_rangeTime Frame:
    2 min, 5 min, 10 min
    enhanced_encryption
    Safety Issue:
    no
  • Evaluation of the cooling/soothing effect (scores) after first and second application
    date_rangeTime Frame:
    2 min, 5min, 10 min, 15 min
    enhanced_encryption
    Safety Issue:
    no
  • Evaluation of the foam covering properties after first application
    date_rangeTime Frame:
    2 min, 5 min, 10 min, 15 min
    enhanced_encryption
    Safety Issue:
    no
  • Incidence of adverse events
    date_rangeTime Frame:
    FPFV - LPLV
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Evaluation of the effect of Bepanthen burn relief foam spray new formula on a thermic erythema. Equivalence trial. Intra-individual design.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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